NCT07025278尚未招募不适用
The Effects and Mechanisms of Game-based Cognitive-motor Dual-task Intervention on Fall Prevention Among Older Adults
Jinyao Wang0 个研究点目标入组 125 人开始时间: 2027年3月31日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 主要终点
- The changes of Time up and go test from baseline to the end of the intervention
研究概览
简要总结
- Develop an evidence-based dual-task intervention programme incorporating gamification for fall risk reduction in older adults.
- Examine the effects of the gamified dual-task intervention on fall risk in older adults.
- Elucidate the underlying mechanisms of the optimal gamified dual-task intervention programme in reducing falls in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Given the inherent nature of the intervention, blinding of participants and intervention providers was not feasible; only the outcome assessors were kept blinded to group assignment.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years old;
- •Able to walk independently for at least 10 meters without obvious pain or difficulty;
- •Free from lower limb and foot deformities, wounds, ulcers, or other diseases, and capable of wearing flexible devices;
- •Scored as low or moderate fall risk on the Morse Fall Risk Assessment Scale;
- •Scored > 40 points on the Berg Balance Scale and < 20 seconds on the Time Up and Go Test (TUG);
- •Scored ≥ 21 points on the Mini-Mental State Examination (MMSE);
- •With an educational level of primary school or above, able to correctly understand instructions and make corresponding responses;
- •Without diseases that severely affect cognitive and motor functions, including cardiovascular diseases (such as uncontrolled hypertension, heart failure, etc.), neurological diseases (such as Parkinson's disease, stroke, epilepsy, etc.), musculoskeletal diseases (such as severe arthritis, recent fractures, etc.), etc.;
- •Normal vision and hearing or corrected to normal, without affecting the understanding of instructions and participation in interventions;
- •Conscious and able to understand the test requirements;
- •Able to understand and sign the informed consent form voluntarily, and willing to cooperate in completing the research procedures.
排除标准
- •Must rely on assistive walking devices or others to walk;
- •Individuals with color vision disorders, including various types of color blindness and color weakness;
- •Unable to correctly perform addition and subtraction operations;
- •Those allergic to the materials of research equipment;
- •Currently participating in other research or intervention projects that may affect the effectiveness of this intervention.
研究组 & 干预措施
Medium difficulty fixed priority group
Experimental
Participants in this group underwent a medium-difficulty and fixed-priority cognitive-motor dual-task fall prevention intervention program
干预措施: Medium difficulty fixed priority group (Behavioral)
Medium difficulty variable priority group
Active Comparator
Participants in this group underwent a medium-difficulty and variable-priority cognitive-motor dual-task fall prevention intervention program
干预措施: Medium difficulty variable priority group (Behavioral)
结局指标
主要结局
The changes of Time up and go test from baseline to the end of the intervention
时间窗: From enrollment to the end of the intervention at 3 weeks
次要结局
- The changes of the Berg Balance Scale (BBS) from baseline to the end of the intervention(From enrollment to the end of the intervention at 3 weeks)
- The changes of the Mini-Mental State Examination (MMSE) from baseline to the end of the intervention(From enrollment to the end of the intervention at 3 weeks)
- The changes of Trail making test from baseline to the end of the intervention(From enrollment to the end of the intervention at 3 weeks)
- The changes of gait from baseline to the end of the intervention(From enrollment to the end of the intervention at 3 weeks)
研究者
Jinyao Wang
Principal Investigator
West China Hospital
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